Indwelling luminal devices

ABSTRACT

The invention comprises an indwelling medical device which is capable of delivering a therapeutic agent evenly along the length of the indwelling portion, including the outer wall, of the device.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/936,065, filed Nov. 9, 2015, now U.S. Pat. No. 10,625,049, issuedApr. 21, 2020, which is a continuation of U.S. patent application Ser.No. 13/228,330, filed Sep. 8, 2011, now U.S. Pat. No. 9,180,274, issuedNov. 10, 2015, which claims priority to U.S. Provisional PatentApplication No. 61/381,358, filed Sep. 9, 2010, which are herebyincorporated by reference herein in their entireties.

FIELD OF INVENTION

The invention relates generally to medical devices for the treatment ofvarious medical conditions and specifically to indwelling catheters usedto treat a patient's bloodstream.

BACKGROUND OF THE INVENTION

Implanted medical devices such as venous and arterial catheters,neurological prostheses, wound drains, urinary catheters, central venouscatheters, peritoneal catheters, shunts, and other luminal indwellingdevices, are useful for treating various medical conditions. However, adrawback of implanted medical devices is the risk of infection while themedical device is inserted in the body, and thereafter. Such risk existseven though the medical devices are sterilized and carefully packaged toguard against introduction of microbes or pathogens during implantationor insertion of the medical device. For example, there is a risk ofserious nosocomial infections when using catheters for hemodialysisprocedures. In fact, central venous catheters account for mostnosocomial catheter-related bloodstream infections.

When catheters and other indwelling luminal devices are inserted intobody cavities such as the urinary tract, venous or arterial vessels,bacteria or other microbes can be picked up from the skin and carriedinto the insertion site where bacterial or microbial colonization mayensue. Infections may derive from an interaction of the microbes and thecatheter micro-surface. Once infected, the microorganisms adhere to thecatheter micro-surface and rapidly become encased in a polysaccharidematrix or biofilm, which protects the microorganisms from a host'sdefenses.

In the case of urinary and venous catheters, there is a significantthreat of microbial growth along the exterior surface or outer wall ofthe catheter and, especially for catheters used long-term, there is asignificant threat of microbial growth along the interior surface orinner wall. This can lead to chronic urinary tract infections (CUTI), orsepticemia in the case of venous and arterial catheters, thrombolyticemboli, stenosis, and thrombosis resulting from infections, and otherlife threatening complications, especially among the elderly andimmuno-compromised patients. Thus, there is a need for the developmentof better methods of preventing and treating infections caused by theinsertion of catheters into a patient's body.

In addition to antimicrobials, other therapeutic agents may help reducecomplications associated with chronically implanted indwelling medicaldevices in the body of a patient. Such medications includeanti-inflammatories, anti-proliferatives and anti-coagulating agents ora combination thereof. However, to be effective the therapeutic agentshould be delivered to a substantial portion of the surface of theindwelling medical device. Without such therapeutic agents, there is arisk that portions of the medical device will become compromised andcause an inflammatory response and/or allow tissue in-growth oversurfaces of the indwelling portion of the medical device.

Other drawbacks of conventional indwelling catheters include asignificant crossing profile, lack of convenience, and tissue damage tothe areas to which the catheters are deployed. For example, indwellingcatheters are typically used only periodically. As a result,inconvenient characteristics of catheters, such as being difficult tothread or insert catheter bodies, add to the treatment time andpotential discomfort of therapy provided by the catheter. Also, asdiscussed above, indwelling catheters, such as central venous catheters,may cause damage to a patient's vasculature.

Accordingly, there is a need for a medical device that can effectivelydeliver a therapeutic agent to a substantial portion of its surface,e.g. a substantial length of the outer surface of an indwellingcatheter. In addition, improved devices are needed which feature a lowerprofile, more convenient method of use, and reduce tissue damage causedto a patient's anatomy.

SUMMARY OF THE INVENTION

One embodiment of the invention comprises an indwelling catheter havinga central tube with at least one lumen and an outer jacket surroundingsaid tube. In various embodiments, the indwelling catheter is a centralvenous catheter. In various embodiments, the catheter further comprisesa plurality of grooves in the outer surface of the central tube, whereinthe grooves and jacket form a plurality of channels extending along atleast a portion of the longitudinal axis of the catheter.

In one embodiment, the central tube is internally segmented into aplurality of lumens. In another embodiment, the central tube comprisestwo lumens. In another embodiment, the outer surface of the central tubeis generally circular. In another embodiment, the outer surface of thecentral tube is generally an oval. In another embodiment, thecross-section of the lumen is d-shaped. In another embodiment, thecross-section of the lumen is circular.

In various embodiments, said lumens are each in fluid communication withat least one extension tube. In another embodiment, the extension tubeseach comprise a connector hub. In another embodiment, the channels arein fluid communication with an extension tube. In another embodiment, atleast two extension tubes are in fluid communication with differentchannels. In another embodiment, the channels are in deflectable legswhich can be positioned against the walls.

In various embodiments, the jacket is permeable. In various embodiments,the jacket is porous. In another embodiment, the jacket comprises ePTFE.

In various embodiments, the catheter further comprises a secondary tube.In various embodiments, the secondary tube concentrically surrounds thecentral tube and jacket. In other embodiments, the secondary tubespirals around the surface of the central tube and jacket. The secondarytube may also comprise a sleeve inserted into the patient's vasculature.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary medical device which comprises anindwelling catheter and extension tubes.

FIGS. 2A and 2B illustrate cross sections of two exemplary indwellingcatheters at “A-A” in FIG. 1.

FIGS. 3A and 3B illustrate the distal end of the indwelling cathetersdepicted in FIGS. 2A and 2B.

FIGS. 4A and 4B illustrate, respectively, a perspective view and a crosssection of an exemplary medical device comprising a “Chinese lantern”type anchoring device.

FIG. 5 illustrates a cross section of an exemplary medical device.

FIGS. 6A and 6B illustrate side views of an exemplary medical device.

FIG. 7 illustrates a side view of another exemplary medical device,comprising a “pigtail” type anchoring device.

FIG. 8 illustrates a side view of an exemplary medical device comprisinga secondary tube.

FIG. 9 illustrates a side view of another exemplary medical devicecomprising a secondary tube.

FIGS. 10A and 10B illustrate a side view of an exemplary medical devicecomprising a secondary tube.

FIGS. 11A and 11B illustrate an exemplary medical device comprising aport.

FIGS. 12A and 12B illustrate an exemplary medical device comprising asupport wire path and support wire.

FIG. 13 illustrates an exemplary medical device comprising a dockingstation.

DETAILED DESCRIPTION OF THE INVENTION

While the present invention will hereinafter be described in connectionwith the preferred embodiments, it will be understood that it is notintended to limit the invention to these embodiments. Instead, it isintended to cover all alternatives, modifications, and equivalents asmay be included within the spirit and scope of the invention asdescribed and claimed.

For the purposes of the following description and the claims appendedhereto, the term “distal” refers to those portions of a medical device,such an indwelling catheter, and those portions of components of themedical device which are nearest the insertion tip, that is, the end ofthe medical device that is inserted into an area of a patient's body,such as a blood vessel. Conversely, the relative term “proximal” refersto those portions of a medical device and those portions of componentswhich are farthest from the insertion tip of the catheter.

Various exemplary medical devices in accordance with the disclosurecomprise a central tube with at least one lumen, a second lumen, and anouter jacket concentrically surrounding the central tube. In variousexemplary embodiments, the second lumen is comprised within the centraltube and the two lumens are of equal cross-sectional surface area. Inother exemplary embodiments, the second lumen is configured annularlybetween the outer surface of the central tube and the inner surface ofthe outer jacket. In yet other exemplary embodiments, the medical devicecomprises a secondary tube which comprises the second lumen.

In another embodiment of the invention, the medical device comprises anindwelling catheter. Said indwelling catheter can comprise a portionthat is accessible from outside the body once said indwelling portion isinserted into the body. Any catheter used for medical treatment cangenerally be used for the present invention. Suitable catheters include,but are not limited to, venous, arterial, urinary catheters, wounddrains, central venous catheters, peritoneal catheter, percutaneouscatheters, sheaths and trocars, drainage catheters, endoscopes andendoscopic catheters, and gastrointestinal catheters. In addition tocatheters, other medical devices that are insertable into the body of apatient, and accessible through the skin or other method once implantedcan be used in the present invention. For example, the following otherindwelling medical devices may be used: cannulas, cardiac pacing leadsor lead tips, cardiac defibrillator leads or lead tips, implantablevascular access ports, blood tubing, vascular or other grafts,intra-aortic balloon pumps, heart valves, cardiovascular sutures, totalartificial hearts and ventricular assist pumps.

Referring to the drawings, like reference numbers represent like orcorresponding elements in the drawings. The drawings illustrate oneembodiment of the instant invention. Other medical devices are alsocontemplated as part of the instant invention.

With reference to FIG. 1, exemplary medical device 100 is illustrated.Medical device 100 comprises an indwelling catheter 104. Medical device100 further comprises extension tubes 106, 108 and 110, which are influid communication with lumens and channels (or annual spaces) withinindwelling catheter 104. Medical device 100 further comprises connectorhubs 112, 114 and 116, which are attached to the proximal ends ofextension tubes 106, 108 and 110, respectively.

The proximal portion of medical device 100 comprises a central tube 102which houses a plurality of single lumen proximal extension tubes, 106,108 and 110. Proximal extension tubes 106, 108, and 110 each have adistal end and a proximal end. The distal end of each proximal extensiontube is connected to the proximal end of central tube 102 such that thesingle lumen of each proximal extension tube is in fluid communicationwith one of the plurality of lumens of central tube 102. In addition, atleast one single lumen extension tube is attached to a plurality ofchannels (not shown). In another embodiment, several extension tubes canbe attached to the plurality of channels. In another embodiment,extension tubes 106, 108 and 110 may be removable.

In one embodiment, medical device 100 comprises a polymer, such aspolyethylene, polyurethane, polycarbonates, ethyl vinyl acetate,polyamides (such as PEBAX®, a registered trademark of Arkema),polyimides, or similar material.

FIG. 2A illustrates a cross-sectional view of an exemplary medicaldevice 200 at “A-A” in FIG. 1. Central tube 202 of medical device 200 isgenerally circular. Central tube 202 comprises a biocompatible polymericmaterial. A biocompatible material is hereby defined as a material beingsuited for and meeting the purpose and requirements of a medical device,used for either long or short term implants or for non-implantableapplications. Long term implants are defined as items implanted for morethan 30 days. Exemplary polymeric materials include without limitationpolyurethane and its copolymers, silicone and its copolymers, ethylenevinyl-acetate, polyethylene terephtalate, thermoplastic elastomers,polyvinyl chloride, polyolefins, cellulosics, polyamides,polyether-amides, polyesters, polyimides, polysulfones,polytetrafluorethylenes, polycarbonates, acrylonitrile butadiene styrenecopolymers, acrylics, polylactic acid, polyglycolic acid,polycaprolactone, polylactic acid-polyethylene oxide copolymers,cellulose, collagens, and chitins, and other various copolymers.

In an aspect of exemplary medical device 200, central tube 202 isinternally segmented into lumens 206 and 208. Lumens 206 and 208 areparallel and have substantially the same “d-shaped” cross-sectionalsurface area.

In various exemplary embodiments, central tube 202 and jacket 210comprise a highly flexible material, such as ePTFE. In thisconfiguration, central tube 202 and jacket 210 are sufficiently flexiblesuch that they are buoyant in the blood flow within the vessel. Theflexible material also provides adequate support to allow medical device200 to retain its overall shape while in operation. For example, centraltube 202 has sufficient column strength to prevent the tube fromcollapsing when vacuum or suction is applied to it during a medicalprocedure. This flexibility and buoyancy helps to reduce the forceand/or impact at which that medical device 200 makes contact with thewalls of the treatment vessel, thereby minimizing tissue damage andreducing the likelihood of occurrences of vascular stenosis.

In various exemplary embodiments, central tube 202 further comprisesheparin. Heparin may be attached to any surface of the central tube 202.A coating of heparin can help prevent and/or reduce thrombosis formationon or in central tube 202. In one exemplary embodiment, the surfaces oflumens 206 and 208 comprise a heparin coating. In another embodiment,the outer surface of central tube 202 comprises a heparin coating. Theheparin coating and method of attaching a heparin coating is taught inU.S. Pat. No. 6,559,132, which is incorporated by reference herein inits entirety for all purposes.

One embodiment of the invention comprises an indwelling medical devicethat can effectively deliver a therapeutic agent evenly along thelength, of said medical device. For the purposes of this invention“length” comprises at least a portion of the length of a medical deviceand its surface (i.e. outer wall), unless otherwise stated.

In this regard, in exemplary embodiments, central tube 202 furthercomprises a plurality of grooves 204 extending along its longitudinalaxis. Grooves 204 may be positioned in the outer surface of central tube202. In this configuration, the combination of grooves 204 and outerjacket 210 forms a plurality of channels 212 extending along thelongitudinal axis of said central tube and jacket. In one aspect of theexemplary embodiment, grooves 204 are formed during extrusion of centraltube 202. In another aspect, grooves 204 are formed by cutting thegrooves into the outer wall of central tube 202, such as, for example,with a laser. Further, grooves 204 may be formed by reflowing the outersurface of central tube 202 around longitudinal features.

One of the advantages of having channels 212 along the longitudinal axisof the medical device is that when a fluid is infused into the channels,it evenly distributes the fluid along its length which can then diffuseto the outer wall of the medical device and/or to the surroundingenvironment in which the medical device is dwelling.

Grooves 204 may be configured in any shape, e.g. square, round orcombinations thereof. Grooves 204 may continue down the entire length ofcentral tube 202 or a portion thereof. In various exemplary embodiments,channels 212, which are formed by grooves 204 interfacing with jacket210, carry liquids and/or gases from the proximal end to the distal endof medical device 202.

Jacket 210 of medical device 200 may comprise a permeable and/or porousmaterial. Examples of such porous materials include, but are not limitedto, porous fluoropolymers such as expanded polytetrafluoroethylene(ePTFE), expanded high density polyethylene (HDPE). Other non-porouspolymers such as polyesters, polyurethanes, polyethylenes, polyimides,etc. can also be of utility provided they are processed to have pores.Examples of such processes include laser perforation and pinperforations. Jacket 210 may also comprise semi-permeable films, such aspolyurethanes, silicones, and polyether-amides. As used herein, the term“porous” describes a material that contains small or microscopicopenings, or pores. Without limitation, “porous” is inclusive ofmaterials that possess pores that are observable under microscopicexamination. The term “porous” describes a material through which fluids(liquid and/or gas) can penetrate through bulk flow. A permeablematerial prevents bulk flow while allowing selective molecules to pass,while a porous material can allow bulk flow while restricting flow ofcertain size particles.

Selecting porosity and/or permeability of the jacket material cangenerate a back pressure within channels 212 which aids in an evendistribution of fluid down the length of the device, as opposed to amore porous or permeable structures that provide for flow to only asection of channels 212 with the least resistance. For example, ifmedical device 200 is located against the wall of a vessel, flow may berestricted and therapeutic agents will only be delivered to the sectionsthat are not in contact with the vessel. If there was a jacket 210 thatcomprises a material with sufficient back pressure, the effect of wallcontact on distribution will be minimized. Such a material can bedesigned, inter alia, by adjusting the porosity and/or permeability ofthe jacket material. Furthermore said jacket material may be adjusted bytaking into account (or adjusting) the physical properties of the fluid(including any active agents and/or excipients in the fluid) by methodsknown in the art.

A therapeutic agent is a drug or agent that can elicit a bioactiveresponse. Examples of the therapeutic agents or drugs useful in thisinvention include prochlorperazine edisylate, ferrous sulfate,aminocaproic acid, mecaxylamine hydrochloride, procainamidehydrochloride, amphetamine sulfate, methamphetamine hydrochloride,benzphetamine hydrochloride, isoproteronol sulfate, phenmetrazinehydrochloride, bethanechol chloride, methacholine chloride, pilocarpinehydrochloride, atropine sulfate, scopolamine bromide, isopropamideiodide, tridihexethyl chloride, phenformin hydrochloride,methylphenidate hydrochloride, theophylline cholinate, cephalexinhydrochloride, diphenidol, meclizine hydrochloride, prochlorperazinemaleate, phenoxybenzamine, thiethylperazine maleate, anisindione,diphenadione, erythrityl tetranitrate, digoxin, isoflurophate,acetazolamide, methazolamide, bendroflumethiazide, chlorpropamide,tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminumaspirin, methotrexate, acetyl sulfisoxazole, hydrocortisone,hydrocorticosterone acetate, cortisone acetate, dexamethasone and itsderivatives such as betamethasone, triamcinolone, methyltestosterone,17-β-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether,prednisolone, 17-β-hydroxyprogesterone acetate, 19-nor-progesterone,norgestrel, norethindrone, norethisterone, norethiederone, progesterone,norgesterone, norethynodrel, indomethacin, naproxen, fenoprofen,sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol,timolol, atenolol, alprenolol, cimetidine, clonidine, imipramine,levodopa, chlorpromazine, methyldopa, dihydroxyphenylalanine,theophylline, calcium gluconate, ketoprofen, ibuprofen, atorvastatin,simvastatin, pravastatin, fluvastatin, lovastatin, cephalexin,erythromycin, haloperidol, zomepirac, ferrous lactate, vincamine,phenoxybenzamine, diltiazem, milrinone, captropril, mandol, quanbenz,hydrochlorothiazide, ranitidine, flurbiprofen, fenbufen, fluprofen,tolmetin, alclofenac, mefenamic, flufenamic, difuninal, nimodipine,nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine,tiapamil, gallopamil, amlodipine, mioflazine, lisinopril, enalapril,captopril, ramipril, enalaprilat, famotidine, nizatidine, sucralfate,etintidine, tetratolol, minoxidil, chlordiazepoxide, diazepam,amitriptylin, and imipramine. Further examples are proteins and peptideswhich include, but are not limited to, insulin, colchicine, glucagon,thyroid stimulating hormone, parathyroid and pituitary hormones,calcitonin, renin, prolactin, corticotrophin, thyrotropic hormone,follicle stimulating hormone, chorionic gonadotropin, gonadotropinreleasing hormone, bovine somatotropin, porcine somatropin, oxytocin,vasopressin, prolactin, somatostatin, lypressin, pancreozymin,luteinizing hormone, LHRH, interferons, interleukins, growth hormonessuch as human growth hormone, bovine growth hormone and porcine growthhormone, fertility inhibitors such as the prostaglandins, fertilitypromoters, growth factors, and human pancreas hormone releasing factor.In an exemplary embodiment, the therapeutic agent is a steroid, such asdexamethasone. Additional exemplary embodiments comprise therapeuticagents consisting of mixtures of anti-microbials, antivirals,antibiotics, antibacterial agents, anti-inflammatory agents,anti-proliferative agents, anti-coagulating agents, hemostatic agents,decongestants, hemorrhoidal treatments, and/or analgesics.

The fluid interaction with jacket 210 is important for evendistribution. If the therapeutic agent to be delivered to thevasculature is of high viscosity or has a surface energy that restrictsand/or prevents passage through jacket 210, the pore size, structureand/or surface energy of jacket 210 can be tailored to obtain theoptimized fluid mechanics for a desired dosing regimen. In an exemplaryembodiment, a therapeutic agent is substantially evenly distributedalong the length of the medical device. In an aspect of theseembodiments, jacket 210 is a highly porous material, which allows asubstantial amount of therapeutic agent to evenly perfuse out along thelength of medical device 200. In other aspects of these embodiments,jacket 210 has a low degree of porosity, and therefore the therapeuticagent may dwell within the channel 212 and wick out slowly over a periodof time.

For example, if wicking of the therapeutic agent is used to eitherprovide for a slow delivery (spanning the course of multiple hours, daysand/or treatment cycles) or a more even delivery of a therapeutic agent,then the microstructure and surface energy of jacket 210 must betailored to allow for wicking of the therapeutic agent. Wicking may beused to provide a therapeutic agent to the areas of outer jacket 210that are over the non-grooved portions of the surface of central tube202.

In addition, channels 212 may be designed to function as a reservoir toallow for the storage of an appropriate amount of a therapeutic agent.For instance, if the device is intended to supply a therapeutic agent tothe surface of jacket 210 over the course of multiple days, and the rateof delivery is known, the required volume for channels 212 to functionas reservoirs can be calculated. If additional volume is required, anadditional reservoir can be located external to the patient or in anadditional volume internal to the central tube 202.

In various exemplary embodiments, jacket 210 further comprises a heparincoating. In various embodiments, both jacket 210 and the outer surfaceof central tube 202 comprise a heparin coating.

In various exemplary embodiments, jacket 210 may further comprise acoating of therapeutic agents. In some exemplary embodiments, thetherapeutic agent would be bound to the outer surface of jacket 210. Inother embodiments, the therapeutic agent would pass through jacket 210into the vasculature via pores or permeations in jacket 210.

In other exemplary embodiments, jacket 210 comprises a hydrogel coating.In these configurations, therapeutic agents may be absorbed by thehydrogel as they exit the pores and/or permeations in jacket 210. Thetherapeutic agents may also be formed as a hydrogel and applied to thesurface of or otherwise dissociating from jacket 210. The therapeuticagent would be released by the hydrogel into the blood stream at asignificantly slower rate, preventing the drug from sloughing off ofjacket 210. In yet other exemplary embodiments, a beneficial gas, suchas nitrous oxide, may be passed through channels 212 and out of jacket210 into the patient's blood stream.

With reference to FIG. 2B an exemplary medical device 300 isillustrated. Medical device 300 comprises a central tube 302, grooves304, and an outer jacket 310. In this exemplary embodiment, central tube302 is generally oval in shape, and is segmented into lumens 306 and308. Lumens 306 and 308 are substantially parallel and have the samegeneral circular shape. In an aspect of the exemplary embodiment, lumens306 and 308 may have substantially the same cross-sectional surfacearea.

FIGS. 3A and B illustrate the distal end of the exemplary medicaldevices depicted in FIGS. 2A and 2B. Specifically, FIG. 3A illustratesthe distal end of medical device 200. FIG. 3B illustrates the distal endof medical device 300. As illustrated in FIGS. 3A and 3B, the lumens206, 208, 306 and 308 extend from the proximal to the distal end of themedical device. However, in a preferred embodiment, the channels willnot be open at the distal end so that when fluid is infused into thechannel, the fluid will not flow out of the distal end of the channel.

With reference to FIGS. 4A and 4B, an exemplary medical device 400 isillustrated. Medical device 400 further comprises an anchor segment 420of outer tube 404. Anchor segment 420 may be located at the distal endof outer tube 404. In an aspect of the exemplary embodiment, anchorsegment 420 may comprise a series of “legs” which are in contact withthe vessel walls, and act to center and stabilize medical device 400within the vessel. Such a configuration may help to minimize the risk ofvenous stenosis by preventing medical device 400 from damaging and/orabrading adjacent tissues.

In an aspect of the exemplary embodiment, the anchor segment 420 may beconfigured as a “Chinese lantern” shape. In this configuration, the legsof anchor segment 420 may be deployed from a relaxed configuration, inwhich they are substantially parallel to central tube 402, to anexpanded configuration, in which they contact the vessel walls in a“Chinese lantern” shape. In a preferred embodiment, central tube 402 isfixedly attached to the distal end of anchoring segment 420. Centraltube 402 is partially withdrawn axially through outer tube 404, whichcauses the legs of anchoring segment 420 to expand and contact the wallsof the treatment vessel.

Anchor segment 420 may further comprise at least one individual lumenwithin each “leg” with communication to the outside surface via holes orports. In this configuration, therapeutic agent may be delivered throughthe individual lumens directly to the point where the legs of anchorsegment 420 contact the vessel wall. In another aspect of the exemplaryembodiment, the legs of anchor segment 420 are configured as a tubularconstruct having a plurality of grooves on their outer periphery. Thegrooves may deliver therapeutic agents directly to the vessel walls.Outer tube 404 may comprise a material of sufficient porosity and/orpermeability to deliver therapeutic agents at the points which outertube 404 contacts the vessel wall, thereby efficiently deliveringsmaller doses of therapeutic agents directly to targeted tissue andpreventing drugs from washing downstream into the circulatory system.

With initial reference to FIG. 5, in various exemplary embodiments,medical device 500 comprises a central tube 502, an outer tube 504 andan outer jacket 510. Outer tube 504 concentrically surrounds centraltube 502, creating an annular lumen 508. Outer jacket 510 concentricallysurrounds the outer surface of outer tube 504. Central tube furthercomprises a central lumen 506.

In various exemplary embodiments, outer tube 504 further comprises aplurality of grooves 512 extending along its longitudinal axis. Grooves512 may be positioned in the outer surface of outer tube 504. In thisconfiguration, a plurality of channels extend along the longitudinalaxis of outer tube 504 and outer jacket 510. As discussed earlier inrelation to exemplary medical device 200, grooves 512 may be formed, forexample, by cutting grooves into the outer wall of outer tube 504,reflowing the outer surface of outer tube 504, or created duringextrusion of outer tube 504.

In various exemplary embodiments, these channels may be in fluidcommunication with a supply of beneficial drugs or agents. As previouslydiscussed in relation to exemplary medical device 200, themicrostructure of jacket 510 and position and configuration of thechannels may control the flow rate of a beneficial drug or agent intothe treatment vessel.

With reference to FIGS. 6A and 6B, in various exemplary embodiments,medical device 600 comprises a central tube 602, an outer tube 604, anda jacket 610. Outer tube 604 concentrically surrounds central tube 602,creating an annular lumen 608. Jacket 610 concentrically surrounds outertube 604. In accordance with an aspect of the exemplary embodiment,central tube 602 may be longer than outer tube 604 and jacket 610,therefore protruding from outer tube 604 and jacket 610 at their distalends.

In various exemplary embodiments, outer tube 604 further comprises aplurality of grooves extending along its longitudinal axis. Thesegrooves may be positioned in the outer surface of outer tube 604. Inthis configuration, a plurality of channels extending along thelongitudinal axis of outer tube 604 and outer jacket 610. These channelsmay be in fluid communication with a supply of beneficial drugs oragents. As previously discussed in relation to exemplary medical device200, the microstructure of jacket 610 and position and configuration ofchannels may control the flow rate of a beneficial drug or agent intothe treatment vessel.

In various exemplary embodiments, medical device 600 may furthercomprise a distal tip 616 attached to the distal end of central tube602. Distal tip 616 may comprise opening 606 and terminate in a tip. Invarious exemplary embodiments, distal tip 616 is wedge, “duck-bill,” orflapper-shaped. However, any shape of distal tip 616 which allows fortreated blood to exit through opening 606 is within the scope of thepresent disclosure.

In this configuration, the distal tip 616 protrudes from the outer tube604 when medical device 600 is in operation, as illustrated in FIG. 6B.During operation, blood to be treated flows in to medical device 600through annular lumen 608. The blood is treated outside of the body, andthe treated blood flows back in to the vessel through opening 606 and asthe blood exits distal tip 616. When medical device 600 is not inoperation, as illustrated in FIG. 6A, distal tip 616 may be retractedsuch that it seats inside the distal end of outer tube 604, sealing theend of annular lumen 608. Any shape and configuration of distal tip 616which provides a return path for treated blood and is capable of sealinglumen 608 when the medical device is not in operation is within thescope of the present disclosure. In addition, any shape of lumen,including annular or one or more channels, which provides an outflowpath for blood from the vessel is within the scope of the presentinvention.

In various exemplary embodiments, distal tip 616 comprises a relativelysoft biocompatible material, such a silicone. In such embodiments,central tube 602 may comprise a more rigid biocompatible material, suchas polyurethane. A more rigid material than is used in other exemplaryembodiments is permissible in this configuration because central tube602 is only exposed when medical device 600 is in operation, and the endof the tube features a relatively soft distal tip 616. Therefore,central tube 602 is unlikely to make inadvertent contact with the vesselwalls and cause unintended tissue damage. However, central tube 602 maycomprise any material which is biocompatible and provides sufficientstructure, including materials discussed in regards to other exemplaryembodiments.

With reference to FIG. 7, medical device 700 may comprise a central tube702 which contains a single lumen 706 and extends beyond the distal endof an outer tube 710. In various exemplary embodiments, the portion ofcentral tube 702 which extends beyond the distal end of outer tube 710may change shape and configuration. For example, the exposed portion ofcentral tube 702 may be configured in a “pigtail” configuration. In thisembodiment, the “pigtail” is made by forming the distal end of centraltube 702 into a spiral at the distal region large enough in diameter tocontact adjacent tissues. In this configuration, the “pigtail” shape ofthe exposed portion of central tube 702 positions and centers medicaldevice 700 in the treatment vessel by contacting the side walls of thevessel. This positioning helps to reduce inadvertent contact betweenmedical device 700 and the walls of the treatment vessel, minimizingdamage to the tissue and reducing the risk of vascular stenosis.

In various exemplary embodiments, medical devices in accordance with thepresent disclosure may further comprise a secondary tube. As illustratedin FIG. 8, secondary tube 803 may be configured to spiral along theoutside of central tube 802. In this configuration, secondary tube 803houses second lumen 808.

Secondary tube 803 may comprise, for example, a biocompatible material.Such materials may include olefin polymers, polyethylene, polypropylene,polyvinyl chloride, polytetrafluoroethylene which is not expanded,fluorinated ethylene propylene copolymer, polyvinyl acetate,polystyrene, poly(ethylene terephthalate), naphthalene dicarboxylatederivatives, such as polyethylene naphthalate, polybutylene naphthalate,polytrimethylene naphthalate and trim ethylenediol naphthalate,polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates,polyaldehydes, natural rubbers, polyester copolymers, styrene-butadienecopolymers, polyethers, such as fully or partially halogenatedpolyethers, copolymers, and combinations thereof. Also, polyesters,including polyethylene terephthalate (PET) polyesters, polypropylenes,polyethylenes, polyurethanes, polyolefins, polyvinyls,polymethylacetates, polyamides, naphthalane dicarboxylene derivatives,and natural silk may be used.

In an aspect of the exemplary embodiments, secondary tube 803 mayprovide structural support to medical device 800. Central tube 802 andsecondary tube 803 may comprise a flexible material, such as ePTFE,which allows central tube 802 and secondary tube 803 to be in acollapsed configuration when medical device 800 is not in use. Whenmedical device 800 is in operation, blood returning to the vessel fromtreatment inflates secondary tube 803, providing structural support tocentral tube 802. When medical device 800 is not in operation, centraltube 802 will float in the flow of blood within the treatment vessel.This configuration reduces the force and/or impact with which medicaldevice 800 contacts the walls of the treatment vessel, decreasing tissuedamage and reducing the risk of vascular stenosis.

With reference to FIG. 9, an exemplary medical device 900 comprises asecondary tube 903 which surrounds central tube 902. In variousexemplary embodiments, central tube 902 and secondary tube 903 maycomprise multiple configurations. For example, central tube 902 andsecondary tube 903 may comprise an expanded configuration when medicaldevice 900 is in operation and a collapsed configuration when medicaldevice 900 is not in operation. As used herein, “expanded” means beingswelled, unfurled or otherwise having an increased diameter and/or anincreased volume. “Collapsed” means being compressed, closed, furled orotherwise having a decreased diameter and/or a decreased volume.

For example, secondary tube 903 may comprise an inflatable sleeve whichextends from the distal end of medical device 900 to the proximal end ofcentral tube 902. When medical device 900 is in operation, secondarytube 903 inflates to an expanded configuration and provides structuralsupport to central tube 902. In an aspect of these exemplaryembodiments, secondary tube 903 inflates to a diameter that makescontact with the inner vessel walls. When medical device 900 is not inoperation, secondary tube 903 deflates to a collapsed configuration inwhich the tube does not contact the inner vessel walls. The expansionand collapse of secondary tube 903 may reduce the formation of biofilmand/or biofouling on the outside surface of the tube.

In various exemplary embodiments, secondary tube 903 may comprise aperforated material, such as ePTFE. In this configuration, treated bloodis returned to the treatment vessel through the walls of secondary tube903. In an aspect of various exemplary embodiments, therapeutic agentmay also pass through the secondary tube 903 and into the treatmentvessel. Secondary tube 903 may also be rendered elastomeric by theincorporation of an elastomeric compound such as is taught in U.S.Patent Application Publication 2004/0024448 to Chang et al., which isincorporated by reference herein in its entirety.

With reference to FIGS. 10A and 10B, an exemplary medical device 1000comprises a central tube 1002 and a secondary tube 1003. In variousexemplary embodiments, secondary tube 1003 is a sleeve which may beimplanted in a patient's vasculature. As illustrated in FIG. 10A,central tube 1002 may be inserted into secondary tube 1003 to providetreatment to a patient's vasculature, and removed once treatment hasbeen completed.

In various exemplary embodiments, secondary tube 1003 may comprise anexpanded configuration when medical device 1000 is in operation and acollapsed configuration when medical device 1000 is not in operation.For example, secondary tube 1003 may comprise a collapsible sleeve whichextends from the distal end of medical device 1000 to the proximal endof central tube 1002. When medical device 1000 is in operation, centraltube 1002 is inserted into secondary tube 1003, opening secondary tube1003 to an expanded configuration. When medical device 1000 is not inoperation, central tube 1002 is removed from secondary tube 1003,allowing secondary tube 1003 to collapse.

Secondary tube 1003 may comprise, for example, a highly flexiblebiocompatible polymeric material such as ePTFE. As illustrated in FIG.10B, secondary tube 1003 is flexible enough that, in the absence ofcentral tube 1002, it collapses within the treatment vessel and sealsitself. This prevents blood from flowing back into secondary tube 1003when treatment is not being provided to the patient.

In other exemplary embodiments, secondary tube 1003 may further comprisean anchoring segment. In an aspect of these exemplary embodiments, theanchor segment may be configured as a “Chinese lantern” shape. In thisconfiguration, the legs of the anchor segment may be deployed from acollapsed configuration, in which they are substantially parallel tocentral tube 1002, to an expanded configuration, in which they contactthe vessel walls in a “Chinese lantern” shape. The legs of the anchorsegment may contact the walls of the treatment vessel, stabilizing andcentering medical device 1000 while treatment is delivered to thepatient. Any shape or configuration of the anchor segment which centersand stabilizes medical device 1000 within the treatment vessel is withinthe scope of the invention.

With reference to FIG. 11, an exemplary medical device 1100 comprises acatheter body 1101, which houses a central tube 1102. Medical device1100 further comprises a port 1105 with a port opening 1107 and asecondary tube 1103. Port 1105 is installed in the patient's skin, andsecondary tube 1103 is installed between the subdural portion of port1105 and a treatment vessel 1111. In this configuration, port opening1105 is in fluid communication with treatment vessel 1111 throughsecondary tube 1103.

Catheter body 1101 may be attached to port 1105 and port opening 1107.Central tube 1102 may then be inserted through port opening 1107 intosecondary tube 1103. Central tube 1102 is advanced through secondarytube 1103 into treatment vessel 1111. Once central tube 1102 is inposition within treatment vessel 1111, treatment may begin. Whentreatment has completed, central tube 1102 may be removed from treatmentvessel 1111 and secondary tube 1103 for cleaning or disposal. Portopening 1107 may then be sealed to prevent fluid leakage from thepatient's vasculature.

With reference to FIG. 12, an exemplary medical device 1200 comprises acentral tube 1202, jacket 1210, support wire path 1213, and a supportwire 1214. In this configuration, support wire path 1213 is integral tojacket 1210, and may comprise a spiral-shaped groove in jacket 1210. Asillustrated in FIG. 12A, support wire 1214 may be inserted into supportwire path 1213, providing shape and structural support to central tube1202. Support wire 1214 may comprise a metallic material, such as astainless steel or nitinol stylet. Any material which providessufficient support such that support wire 1214 has adequate strength tomaintain the desired shape of central tube 1202 and jacket 1210 iswithin the scope of the present disclosure.

Once support wire 1214 is inserted into support wire path 1213,treatment may be provided to the patient's vasculature. When treatmenthas concluded, support wire 1214 may be removed from support wire path1213, allowing central tube 1202 to adopt a relaxed configuration.

Central tube 1202 may comprise a relatively flexible material, such asePTFE. The relatively flexible material allows central tube 1202 tofloat in the flow of blood within the treatment vessel, minimizinginadvertent contact with the vessel walls and decreasing potentialtissue damage. Central tube 1202 may comprise any biocompatible materialwhich allows central tube 1202 to assume a relaxed configuration aftersupport wire 1214 is removed.

With reference to FIG. 13, an exemplary medical device 1300 comprises acatheter tube 1302 and docking station 1315. In this configuration,catheter tube 1302 is positioned inside of docking station 1315. Treatedblood is pumped in to docking station 1315. The pressure of thereturning blood flow causes catheter tube 1302 to telescope out ofdocking station 1315, through a port, and into the treatment vessel forthe duration of treatment. Once treatment has completed, catheter tube1302 may be retracted into docking station 1315. In another embodiment,central tube 1303 may be passed through docking station 1315 andinserted into catheter tube 1302 to unfurl, expand, extend and/orprovide support for catheter tube 1302 during a treatment. In anotherembodiment, after treatment, central tube 1303 is removed from cathetertube 1302 allowing retraction and/or retracting catheter tube 1302 intodocking station 1315. Between treatments, a substantial portion and/ordistal end of catheter tube 1302 may remain within docking station 1315.

In various exemplary embodiments, such as those illustrated in FIG. 1,the proximal portion of central tube 102 may comprise a plurality ofsingle-lumen extension tubes 106, 108 and 110. In addition, eachextension tube can comprise a connector hub 112, 114 and 116. Connectorhubs 112, 114 and 116 may be configured for selective sealableattachment between the proximal end of the proximal extension tubes andlegs of a fluid exchange device, or other device, such as a syringe. Inone embodiment, connector hubs 112, 114 and 116 are connectable withmating compression fittings. In another embodiment, connector hubs 112,114 and 116 comprise luer-type fittings. Any attachment means whichpermits connector hubs 112, 114 and 116 to maintain proper fluidcommunication with a fluid exchange device is within the scope of thepresent disclosure.

In various exemplary embodiments, such as those illustrated in thevarious figures, the central tube, jacket, and various lumens may bedisposable. Such disposable embodiments may be discarded after a singletreatment is completed. In other embodiments, various components of themedical devices may be sterilized for re-use. For example, in variousexemplary embodiments, medical devices may be exposed to ultrasonicenergy as a component of the sterilization cycle. However, any techniquewhich sufficiently sterilizes and prepares exemplary medical devices forre-use is within the scope of the present disclosure.

In various exemplary embodiments, medical devices of the presentdisclosure may be cleaned and/or sterilized while they are positioned ina patient's vasculature. For example, ultrasonic energy may be appliedto an exemplary medical device which is positioned in a patient. Theresultant vibration may reduce or remove biofouling, such as biofilm,that has accumulated on the surface of the portion of medical device inthe patient's body.

Numerous characteristics and advantages of the present invention havebeen set forth in the preceding description, including preferred andalternate embodiments together with details of the structure andfunction of the invention. The disclosure is intended as illustrativeonly and as such is not intended to be exhaustive. It will be evident tothose skilled in the art that various modifications may be made,especially in matters of structure, materials, elements, components,shape, size and arrangement of parts within the principals of theinvention, to the full extent indicated by the broad, general meaning ofthe terms in which the appended claims are expressed. To the extent thatthese various modifications do not depart from the spirit and scope ofthe appended claims, they are intended to be encompassed therein. Inaddition to being directed to the embodiments described above andclaimed below, the present invention is further directed to embodimentshaving different combinations of the features described above andclaimed below. As such, the invention is also directed to otherembodiments having any other possible combination of the dependentfeatures claimed below.

1. A medical device comprising: a central tube comprising at least onelumen; and a secondary tube surrounding the central tube such that thecentral tube is insertable into and removable from the secondary tube,the secondary tube having a distal end which collapses and seals uponremoval of the central tube.
 2. The medical device of claim 1, whereinthe secondary tube comprises an inflatable sleeve which extends from adistal end of the central tube to a proximal end of the central tube. 3.The medical device of claim 1, wherein the secondary tube comprises anexpanded configuration when the medical device is in operation and acollapsed configuration when the medical device is not in operation. 4.The medical device of claim 3, wherein the secondary tube is expandableinto the expanded configuration when the central tube is inserted in thesecondary tube.
 5. The medical device of claim 1, wherein the secondarytube comprises flexible biocompatible polymeric material.
 6. The medicaldevice of claim 3, the distal end of the secondary tube comprising aplurality of expandable bent sections which expand into a lantern shapedvessel anchor when the secondary tube is in the expanded configuration.7. The medical device of claim 6, wherein the plurality of expandablebent sections are substantially parallel to the central tube when thesecondary tube is in the collapsed configuration.
 8. The medical deviceof claim 1, wherein the secondary tube comprises perforated material. 9.A method of delivering a therapeutic agent to a vasculature, comprising:preparing a central tube comprising at least one lumen and a secondarytube surrounding the central tube into the vasculature, wherein thecentral tube is insertable into and removable from the secondary tube;inserting the central tube into the secondary tube to expand thesecondary tube into an expanded configuration; delivering thetherapeutic agent to the vasculature from the at least one lumen of thecentral tube; and removing the central tube from the secondary tube tocollapse the secondary tube into a collapsed configuration, causing adistal end of the secondary tube to collapse and seal the secondary tubefrom the vasculature.
 10. The method of claim 9, further comprising:expanding a plurality of expandable bent sections of the secondary tubeinto a lantern shaped vessel anchor when the secondary tube is in theexpanded configuration.
 11. The method of claim 10, wherein theplurality of expandable bent sections are substantially parallel to thecentral tube when the secondary tube is in the collapsed configuration.12. The method of claim 9, wherein the secondary tube comprises flexiblebiocompatible polymeric material.
 13. The method of claim 9, wherein thesecondary tube comprises perforated material.
 14. A medical devicecomprising: a central tube comprising at least one lumen; a secondarytube surrounding the central tube such that the central tube isinsertable into and removable from the secondary tube, the secondarytube having a distal end which collapses and seals upon removal of thecentral tube, and an outer surface of the secondary tube comprising aplurality of grooves extending along the longitudinal axis of thesecondary tube; and an outer jacket surrounding the central tube and thesecondary tube, wherein the grooves and the jacket form a plurality ofchannels extending along at least a portion of the longitudinal axis ofthe secondary tube, and wherein said jacket comprises porous and/orpermeable material such that therapeutic agent can be delivered from thechannels through the porous and/or permeable material of the outerjacket.